The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3551–3575 of 29102

  • SevereFDA (Devices)·Z-1080-2024·2024-02-28

    Surgical ocular packs recalled for loss of saline sterility

    Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.

    Product
    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0343-2024·2024-02-28

    Herbal dietary supplement recalled for undeclared drug ingredient

    Sustain Herbal Dietary Supplement is being recalled nationwide for containing undeclared tadalafil, a pharmaceutical ingredient. The product was marketed as a dietary supplement but contains an unapproved drug.

    Product
    Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1050-2024·2024-02-28

    Dover Foley Catheter Kits Recalled Due to Defective Components

    Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.

    Product
    Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML D
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·24V156000·2024-02-28

    Nissan Rogue seat belt pretensioners may not restrain occupants properly

    Nissan is recalling certain 2023 Rogue vehicles because incorrectly manufactured driver and front passenger seat belt pretensioners may fail to restrain occupants, breaching FMVSS 208, 209 and 210.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1045-2024·2024-02-28

    Dover Foley Catheter and Urinary Drainage Kits Recalled for Defective Components

    Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0346-2024·2024-02-28

    TING Athlete's Foot Spray Recalled Due to Benzene Contamination

    Insight Pharmaceuticals is recalling TING 1% Tolnaftate Athlete's Foot Spray due to benzene contamination. The recall affects approximately 59,644 cans distributed nationwide.

    Product
    TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2024·2024-02-28

    FDA Recalls Neptune's Fix Tianeptine Elixir for Containing Unapproved Drug

    Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.

    Product
    Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0909-2024·2024-02-28

    Hale and Hearty Tomato Basil and Rice Soup Recalled for Undeclared Soy

    Hale and Hearty Soups is recalling Tomato Basil and Rice soup (UPC 635508547872) due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Hale and Hearty Soups; Tomato Basil and Rice; UPC 635508547872
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1048-2024·2024-02-28

    Dover Foley catheter convenience kits recalled due to component defects

    Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, D
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1049-2024·2024-02-28

    Dover Irrigation Convenience Kits Recalled for Component Defects

    Cardinal Health is recalling Dover Irrigation convenience kits that contained components which were separately recalled. The recall affects over 63,000 units distributed across the US, EMEA, Japan, and Latin America.

    Product
    Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0335-2024·2024-02-28

    Neptune's Fix Tianeptine Tablets Recalled for FDA Unapproved Marketing

    Neptune's Fix Tianeptine Tablets are being recalled because the product contains tianeptine, a substance not approved by the FDA for any medical use. The recall affects 4,932 boxes distributed nationwide.

    Product
    Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2024·2024-02-28

    Dietary supplement Arize recalled for undeclared pharmaceutical ingredient

    Arize Herbal Dietary Supplement contains an undeclared ingredient (nortadalafil), a pharmaceutical used in FDA-approved male sexual enhancement medications, making it an unapproved drug.

    Product
    Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V154000·2024-02-27

    Nissan Rogue and Other Models: Driver Air Bag Inflator Recall

    Nissan is recalling certain 2023-2024 vehicles, including the Rogue, due to a manufacturing issue that may allow the driver's air bag inflator to absorb moisture and deploy improperly.

    Product
    INFINITI — INFINITI, NISSAN QX50, redundant KICKS, VERSA, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V152000·2024-02-27

    Toyota Tacoma Recall: Rear Axle Shaft Separation Risk

    Toyota is recalling certain 2022-2023 Tacoma trucks because the rear axle shaft may separate from the axle housing due to debris causing improperly secured fasteners, increasing the risk of a crash.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V145000·2024-02-23

    Kenworth trucks fitted with air tanks holding insufficient brake air

    PACCAR is recalling certain 2009-2024 Kenworth trucks because the air tanks have an insufficient volume of air for the brake system, which can reduce braking performance.

    Product
    KENWORTH — KENWORTH T680, T370, T800, W900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V144000·2024-02-23

    Ford Recalls 2023 F-150 Lightning Vehicles Due to Battery Fire Risk

    Ford is recalling 2023 F-150 Lightning vehicles because loose battery fasteners may cause electrical arcing, increasing the risk of fire or loss of drive power.

    Product
    FORD — FORD F-150 LIGHTNING BEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V143000·2024-02-23

    Ford F-650 and F-750 parking brake levers may release unexpectedly

    Ford is recalling certain 2023-2024 F-650 and F-750 vehicles because the parking brake may malfunction and allow the lever to be released without pressing the release button.

    Product
    FORD — FORD F-650 SD, F-650 INCOMPLETE CHASSIS, F-750 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V132000·2024-02-22

    Jeep Grand Cherokee upper control arm ball joints may separate

    Chrysler is recalling certain 2021-2023 Jeep Grand Cherokee L and 2022-2023 Grand Cherokee vehicles because the upper control arm ball joint and steering knuckle may separate. 338,238 units affected.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24128·2024-02-22

    MouTec Biometric Firearm Safes Recalled for Unauthorized Access Risk

    The CPSC is recalling about 2,200 MouTec brand biometric firearm safes because the biometric lock can be opened by unauthorized users, posing a serious injury hazard and risk of death. One incident involved a 6-year-old opening the safe, though no injuries have been reported.

    Product
    MouTec brand Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24130·2024-02-22

    Bulldog Biometric Firearm Safes Recalled Due to Lock Failure Risk

    Bulldog Cases is recalling about 33,500 Magnum Biometric Pistol Vaults because the biometric lock can fail and be opened by unauthorized users, creating a serious injury hazard and risk of death when firearms are stored in the safe.

    Product
    Bulldog Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24129·2024-02-22

    Machir Biometric Personal Safes Recalled Due to Lock Failure Risk

    Machir LLC recalled about 24,820 biometric personal safes because the biometric lock can fail and allow unauthorized access. The firm received 15 reports of the lock failing to secure safes, posing a serious injury hazard and risk of death if firearms are stored inside.

    Product
    Machir Biometric Personal Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V131000·2024-02-22

    Jeep Grand Cherokee steering knuckles may separate at the ball joint

    Chrysler is recalling certain 2024 Jeep Grand Cherokee vehicles because an improperly machined steering knuckle may separate, causing the wheel to fall outward. 250 units affected.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0980-2024·2024-02-21

    Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation

    Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
    Category
    Medical Device
    Distribution
    Distributed nationwide